Enzumide
Enzalutamide Capsules
Strength
✓40 mg✓160 mg
Pack Size
1 x 28
Drug Class
Antineoplastic
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Enzalutamide is an androgen receptor inhibitor.
The chemical name is 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide.
The molecular weight is 464.44 and the molecular formula is C₂₁H₁₆F₄N₄O₂S.
Enzalutamide is a white crystalline non-hygroscopic solid.
It is practically insoluble in water.
Enzumide is provided as liquid-filled soft gelatin capsules for oral administration.
Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides.
The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
Indicated for the treatment of patients with
- Castration-resistant prostate cancer (CRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Usage
Enzalutamide is used to treat prostate cancer that has spread to other parts of the body in men and who have been helped by certain medical and surgical treatments that decrease testosterone levels.
The efficacy and safety of enzalutamide in patients with metastatic castration resistant prostate cancer who had received docetaxel and were using a gonadotropin-releasing hormone (GnRH) analogue.
Enzalutamide was shown to be an effective and well-tolerated therapeutic option in patients with metastatic castration-resistant prostate cancer.
Safety of enzalutamide in patients with metastatic castration resistant prostate cancer who had received docetaxel and were using a gonadotropin-releasing hormone (GnRH) analogue.
Enzalutamide was shown to be an effective and well-tolerated therapeutic option in patients with metastatic castration-resistant prostate cancer.
Recommended Dosage
The recommended dosage of Enzumide is 160 mg administered orally once daily with or without food.
Swallow capsules or tablets whole.
Do not chew, dissolve, or open the capsules.
Do not cut, crush, or chew the tablets.
Dosage Modifications For Adverse Reactions
If a patient experiences a grade 3 or an intolerable adverse reaction, withhold Enzumide for one week or until symptoms improve to grade 2 or less and then resume at the same or a reduced dose (120 mg or 80 mg) if warranted.
Dosage Modifications for Drug Interactions
Strong CYP2C8 Inhibitors
Avoid the coadministration of strong CYP2C8 inhibitors.
If the coadministration of a strong CYP2C8 inhibitor cannot be avoided, reduce the Enzumide dosage to 80 mg once daily.
If the coadministration of the strong inhibitor is discontinued, increase the Enzumide dosage to the dosage used prior to initiation of the strong CYP2C8 inhibitor.
Strong CYP3A4 Inducers
Avoid the coadministration of strong CYP3A4 inducers.
If the coadministration of a strong CYP3A4 inducer cannot be avoided, increase the Enzumide dosage from 160 mg to 240 mg orally once daily.
If the coadministration of the strong CYP3A4 inducer is discontinued, decrease the Enzumide dosage to the dosage used prior to initiation of the strong CYP3A4 inducer.
Important Administration Instructions
Patients receiving Enzumide should also receive a gonadotropin-releasing hormone (GnRH) analogue concurrently or should have had bilateral orchiectomy.